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FocalTherics (FOCL)
NASDAQ:FOCL
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FocalTherics (FOCL) AI Stock Analysis

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FOCL

FocalTherics

(NASDAQ:FOCL)

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Neutral 48 (OpenAI - Gpt-5.6Sol)
Rating:48Neutral
Price Target:
$4.50
▲(2.51% Upside)
Action:Reiterated
Date:08/28/26
FOCL scores below average primarily due to weak financial performance (deep losses, negative equity, and sustained cash burn). Technical indicators also point to near-term bearish momentum with price below key moving averages. These negatives are partially offset by a notably stronger earnings-call picture—accelerating HIFU revenue growth, rising procedure volumes, and improving gross margin alongside reiterated guidance.
Positive Factors
HIFU Growth and Installed Base
Strong system sales and a larger installed base expand market reach and create a foundation for recurring consumables, service revenue and procedure growth over the next several quarters.
Negative Factors
Persistent Losses and Revenue Contraction
Sustained operating and net losses despite relatively stable revenue indicate that commercialization costs remain too high, limiting internal funding capacity and delaying a durable path to profitability.
Read all positive and negative factors
Positive Factors
Negative Factors
HIFU Growth and Installed Base
Strong system sales and a larger installed base expand market reach and create a foundation for recurring consumables, service revenue and procedure growth over the next several quarters.
Read all positive factors

FocalTherics (FOCL) vs. SPDR S&P 500 ETF (SPY)

FocalTherics Business Overview & Revenue Model

Company Description
EDAP TMS S.A. operates as a holding company, with its subsidiary primarily focused on the innovation, manufacturing, and distribution of advanced, minimally invasive medical devices engineered to address urological conditions. The company's activi...
How the Company Makes Money
EDAP TMS generates revenue primarily by selling and supporting medical device systems used in urology and therapeutic ultrasound procedures. Key revenue streams include: (1) capital equipment sales of its HIFU and other urology-related systems to ...

FocalTherics Earnings Call Summary

Earnings Call Date:Aug 13, 2026
(Q2-2026)
|
% Change Since: |
Next Earnings Date:Nov 05, 2026
Earnings Call Sentiment Positive
The call conveyed clear commercial momentum: double-digit revenue growth (39% YoY), record capital system sales, strong procedure volume growth (47% YoY), margin improvement to 55.6%, meaningful regulatory/reimbursement progress, and a near-term $40M equity raise to fund commercial expansion and R&D. Offsetting these positives are rising operating expenses, a sizable noncash warrant charge ($6.3M) that pushed shareholder equity negative ($-3.2M), reliance on the pending equity raise to strengthen the balance sheet, and a 34% decline in discontinued operations revenue. On balance, the business shows accelerating revenue, improving margins and strategic progress that outweigh the financial and accounting headwinds, with the upcoming equity close expected to materially improve capitalization.
Positive Updates
Strong HIFU Revenue Growth
HIFU revenue of $13.2 million in Q2 2026, up 39% year-over-year from $9.5 million in Q2 2025.
Negative Updates
Rising Operating Expenses and Loss Drivers
Operating expenses increased to $15.4 million in Q2 2026 from $11.5 million in Q2 2025 (≈34% increase). Net loss was impacted by an incremental operating loss of $1.4M and unfavorable FX of $0.4M plus noncash and interest charges.
Read all updates
Q2-2026 Updates
Negative
Strong HIFU Revenue Growth
HIFU revenue of $13.2 million in Q2 2026, up 39% year-over-year from $9.5 million in Q2 2025.
Read all positive updates
Company Guidance
Management reiterated full‑year 2026 continuing‑operations (core HIFU) revenue guidance of $50.0–$54.0 million; Q2 HIFU revenue was $13.2M (up 39% YoY) driven by 13 capital system sales (up 44%) and a worldwide installed base of 184 systems (96 U.S., 88 international), with U.S. procedures up 47% YoY and gross margin rising to 55.6% (from 51.1%); quarter‑end cash was $21.5M (with a $40M underwritten equity offering expected to close Aug 14), shareholder equity was negative $3.2M, Tranche B draws of ~$14M were outstanding under the EIB facility, operating expenses were $15.4M, tariff impact was ~$0.5M, discontinued operations generated $5.6M revenue (‑34%) with 36.4% gross margin and $4.5M inventory, and management noted a proposed ~12% CMS facility payment increase for 2027 and long‑term gross margin aspirations around 60% as it executes its commercial and indication‑expansion strategy.

FocalTherics Financial Statement Overview

Summary
Financials remain weak: TTM revenue declined (~-6.7%) and profitability is deeply negative (EBIT margin ~-39%, net margin ~-56%). The balance sheet is a major risk with negative shareholders’ equity (~-$3.2M) and higher debt (~$39.9M). Cash flow is persistently negative (TTM operating cash flow ~-$12.9M; free cash flow ~-$17.7M), indicating ongoing reliance on external funding.
Income Statement
22
Negative
Balance Sheet
18
Very Negative
Cash Flow
24
Negative
BreakdownTTMDec 2025Dec 2024Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue69.14M70.75M69.35M65.32M57.92M52.08M
Gross Profit31.79M30.09M28.73M26.39M25.43M21.77M
EBITDA-26.43M-25.05M-17.70M-20.31M-915.40K2.66M
Net Income-38.89M-29.34M-20.57M-22.90M-3.08M827.39K
Balance Sheet
Total Assets74.55M79.00M89.12M101.13M107.92M87.82M
Cash, Cash Equivalents and Short-Term Investments21.54M20.45M30.90M48.02M67.38M53.66M
Total Debt39.89M27.68M14.41M9.37M10.02M11.38M
Total Liabilities77.77M59.58M46.77M38.25M31.47M30.90M
Stockholders Equity-3.23M19.41M42.35M62.88M76.45M56.92M
Cash Flow
Free Cash Flow-17.68M-21.40M-16.12M-17.14M-3.82M4.79M
Operating Cash Flow-12.90M-16.46M-14.69M-15.87M-3.18M5.26M
Investing Cash Flow-4.78M-5.73M-4.46M-4.70M-2.50M-1.94M
Financing Cash Flow20.21M8.64M5.01M-984.90K22.85M23.95M

FocalTherics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price4.39
Price Trends
50DMA
5.29
Negative
100DMA
4.64
Negative
200DMA
4.09
Positive
Market Momentum
MACD
-0.36
Positive
RSI
33.92
Neutral
STOCH
50.45
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For FOCL, the sentiment is Negative. The current price of 4.39 is below the 20-day moving average (MA) of 5.00, below the 50-day MA of 5.29, and above the 200-day MA of 4.09, indicating a neutral trend. The MACD of -0.36 indicates Positive momentum. The RSI at 33.92 is Neutral, neither overbought nor oversold. The STOCH value of 50.45 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for FOCL.

FocalTherics Risk Analysis

FocalTherics disclosed 43 risk factors in its most recent earnings report. FocalTherics reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

FocalTherics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
50
Neutral
$41.31M-1.71-79.21%53.42%22.08%
48
Neutral
$162.67M-4.14-289.98%
46
Neutral
$126.37M-14.90-78.70%25.59%55.35%
46
Neutral
$7.85M-0.34-211.73%41.62%20.47%
44
Neutral
$46.30M-4.67-23.45%-14.27%-132.84%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
FOCL
FocalTherics
4.31
2.05
90.71%
APYX
Apyx Medical
3.08
1.09
54.77%
NSPR
InspireMD
0.85
-1.59
-65.16%
XTNT
Xtant Medical Holdings
0.38
-0.26
-39.91%
ICCM
Icecure Medical
2.30
-31.30
-93.15%

FocalTherics Corporate Events

Business Operations and StrategyPrivate Placements and Financing
FocalTherics Completes ADS Offering, Boosting Capital Strength
Positive
Aug 19, 2026
On August 11, 2026, EDAP TMS S.A. entered into an underwriting agreement with TD Securities (USA) LLC and Mizuho Securities USA LLC for an underwritten public offering of 8,425,000 American Depositary Shares at $4.75 per ADS, with the initial offe...
Business Operations and StrategyPrivate Placements and FinancingRegulatory Filings and Compliance
EDAP TMS Announces Underwritten ADS Public Offering
Positive
Aug 14, 2026
On August 11, 2026, EDAP TMS entered into an underwriting agreement with TD Securities (USA) LLC and Mizuho Securities USA LLC for an underwritten public offering of 8,425,000 American Depositary Shares at $4.75 per ADS, with closing expected on A...
Business Operations and StrategyFinancial Disclosures
EDAP TMS Highlights Focal One HIFU Clinical Expansion
Positive
Aug 11, 2026
On August 11, 2026, FocalTherics made an investor presentation available outlining clinical expansion of its Focal One Robotic HIFU platform into benign prostatic hyperplasia and deep infiltrating endometriosis, both currently investigational indi...
Business Operations and StrategyExecutive/Board ChangesPrivate Placements and FinancingShareholder Meetings
EDAP TMS Shareholders Approve Governance and Capital Measures
Positive
Jun 26, 2026
At its Annual General Meeting held on June 26, 2026, EDAP TMS shareholders approved a broad slate of governance and capital-related resolutions, including amendments to key bylaw articles on share capital, the Board of Directors and shareholders&#...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Aug 28, 2026